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SUMMARY OF PRODUCT CHARACTERISTICS

Porcilis Lawsonia ID– product information

1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml reconstituted vaccine contains: Active substance (lyophilisate):

Inactivated Lawsonia intracellularis strain SPAH-08 5323 U1 1 Antigenic mass units as determined in the in vitro potency test (ELISA).

Adjuvant (solvent): Paraffin, light liquid 8.3 mg Dl-α-tocopheryl acetate 0.6 mg

Excipients: For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM Lyophilisate and solvent for emulsion for injection. Lyophilisate: white/nearly white pellet/powder. Solvent: homogenous white to nearly white emulsion after shaking.

4. CLINICAL PARTICULARS

4.1 Target species Pigs.

4.2 Indications for use, specifying the target species For the active immunisation of pigs from 3 weeks of age to reduce diarrhoea, loss of daily weight gain, intestinal lesions, bacterial shedding and mortality caused by Lawsonia intracellularis infection.

Onset of immunity: 4 weeks after vaccination. Duration of immunity: 21 weeks after vaccination.

4.3 Contraindications None.

4.4 Special warnings for each target species Vaccinate healthy animals only.

This vaccine is intended for intradermal administration only. The lyophilisate must be reconstituted in the dedicated “Solvent for Porcilis Lawsonia ID” or in Porcilis PCV ID following the instructions given in section 4.9.


4.5 Special precautions for use Special precautions for use in animals Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

4.6 Adverse reactions (frequency and seriousness)

An increase in body temperature very commonly occurs (mean 0.1°C, in individual pigs up to 1.4°C). The animals return to normal temperature within 1 day after vaccination. Local injection site reactions in the form of swelling may very commonly occur (mean diameter of approximately 1 cm, in individual pigs up to 5 cm). Local reactions disappear within 4 weeks after vaccination. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

4.8 Interaction with other medicinal products and other forms of interaction Safety and efficacy data, except for protection against mortality, are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be mixed with Porcilis PCV ID. The product literature of Porcilis PCV ID should be consulted. Adverse reactions are as described in section 4.6, except for local injection site reactions where a maximum size of up to 7 cm may occur in individual pigs. All local reactions disappear within 5 weeks after vaccination. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route Intradermal use.


Reconstitute the lyophilisate in the solvent or in Porcilis PCV ID as follows:

Lyophilisate Solvent for Porcilis Lawsonia ID or Porcilis PCV ID

50 doses 10 ml

100 doses 20 ml For proper reconstitution and correct administration, use the following procedure:

1. Allow the solvent or Porcilis PCV ID to reach room temperature and shake well before use. 2. Add approximately 5-10 ml of the solvent or Porcilis PCV ID to the lyophilisate vial and mix

briefly. 3. Withdraw the reconstituted concentrate from the vial and transfer it back into the vial with the

solvent or the Porcilis PCV ID. Shake briefly to mix. 4. Use the vaccine suspension within 6 hours of reconstitution. Any vaccine remaining at the end

of this time should be discarded. Avoid introduction of a contamination by multiple broaching. Dosage: A single dose of 0.2 ml of reconstituted vaccine in pigs starting at 3 weeks of age. Vaccinate pigs by the intradermal route using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin. Safety and efficacy of Porcilis Lawsonia ID have been demonstrated using the device IDAL. Visual appearance after reconstitution: homogenous white to nearly white emulsion after shaking.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse reactions other than the local reactions described in section 4.6 were observed after the administration of a double dose of Porcilis Lawsonia ID reconstituted in solvent.

4.11 Withdrawal period(s) Zero days.

5. IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) Lawsonia. ATC-vet code: QI09AB18. The product stimulates the development of active immunity against Lawsonia intracellularis in pigs.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients Lyophilisate: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate


Water for injections Solvent: Paraffin, light liquid Dl-α-tocopheryl acetate Polysorbate 80 Simeticone Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections

6.2 Major incompatibilities Do not mix the lyophilisate with any other veterinary medicinal product, except the recommended “Solvent for Porcilis Lawsonia ID” or the vaccine specified in section 4.8.

6.3 Shelf life Shelf-life of the lyophilisate as packaged for sale: 3 years. Shelf-life of the solvent as packaged for sale: 3 years. Shelf-life after reconstitution according to directions: 6 hours.

6.4 Special precautions for storage

Lyophilisate and solvent:

Store in a refrigerator (2C – 8C). Do not freeze. Protect from light. 6.5 Nature and composition of immediate packaging Lyophilisate: Hydrolytic glass Type I vial of 50 doses or 100 doses closed with halogenobutyl rubber stoppers and sealed with aluminium caps. Solvent: Hydrolytic glass Type I vial of 10 ml closed with nitryl rubber stoppers and sealed with aluminium caps. PET (polyethylene terephthalate) vials of 20 ml closed with nitryl rubber stoppers and sealed with aluminium caps. Presentations: Cardboard box with 1 x 50 doses of vaccine and cardboard box with 1 x 10 ml solvent Cardboard box with 10 x 50 doses of vaccine and cardboard box with 10 x 10 ml solvent Cardboard box with 1 x 100 doses of vaccine and cardboard box with 1 x 20 ml solvent Cardboard box with 10 x 100 doses of vaccine and cardboard box with 10 x 20 ml solvent Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste

materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.


7. MARKETING AUTHORISATION HOLDER [to be completed nationally] Intervet International BV as represented by national companies in the Member States Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS

8. MARKETING AUTHORISATION NUMBER(S) [to be completed nationally]

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD/MM/YYYY}

10. DATE OF REVISION OF THE TEXT [to be completed nationally] {MM/YYYY}

PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.


LABELLING AND PACKAGE LEAFLET


A. LABELLING


PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box with lyophilisate

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Lawsonia ID Lyophilisate for emulsion for injection for pigs

2. STATEMENT OF ACTIVE SUBSTANCES

Inactivated Lawsonia intracellularis: 5323 U/dose

3. PHARMACEUTICAL FORM

Lyophilisate for emulsion for injection

4. PACKAGE SIZE

1 x 50 doses 1 x 100 doses 10 x 50 doses 10 x 100 doses

5. TARGET SPECIES

Pigs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Intradermal use. Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

9. SPECIAL WARNING(S), IF NECESSARY

Accidental self-injection is dangerous.


10. EXPIRY DATE

EXP {month/year}

Once reconstituted use within 6 hours.

11. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze. Protect from light.

12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally] Intervet International BV as represented by national companies in the Member States 5831 AN Boxmeer The Netherlands

16. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally] EU/0/00/000/000

17. MANUFACTURER’S BATCH NUMBER

Lot {number}


PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box with solvent

1. NAME OF THE SOLVENT

Solvent for Porcilis Lawsonia ID

2. STATEMENT OF ACTIVE SUBSTANCES

Per 0.2 ml: Paraffin, light liquid: 8.3 mg Dl-α-tocopheryl acetate: 0.6 mg

3. PHARMACEUTICAL FORM


4. PACKAGE SIZE

1 x 10 ml 1 x 20 ml 10 x 10 ml 10 x 20 ml

5. TARGET SPECIES

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.


Withdrawal period: Zero days.

9. SPECIAL WARNING(S), IF NECESSARY

Accidental self-injection is dangerous.


10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS


12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR

WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally] Intervet International BV as represented by national companies in the Member States 5831 AN Boxmeer The Netherlands

16. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally] EU/0/00/000/000

17. MANUFACTURER’S BATCH NUMBER

Lot {number}


MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Label for lyophilisate

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Lawsonia ID

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

L. intracellularis 5323 U/dose

3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

50 doses 100 doses

4. ROUTE(S) OF ADMINISTRATION

Intradermal use


Withdrawal period: zero days.

6. BATCH NUMBER

Lot {number}

7. EXPIRY DATE

EXP {month/year} Once reconstituted use within 6 hours.

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.


PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE (LABEL) OF THE

SOLVENT

1. NAME OF THE SOLVENT


2. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

10 ml 20 ml

3. ROUTE(S) OF ADMINISTRATION

Read package leaflet before use.

4. STORAGE CONDITIONS


5. BATCH NUMBER

Lot {number}

6. EXPIRY DATE

EXP {month/year}

7. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.


B. PACKAGE LEAFLET


PACKAGE LEAFLET: Porcilis Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH

RELEASE, IF DIFFERENT Marketing authorisation holder: [To be completed nationally] Intervet International BV as represented by national companies in the Member States Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer responsible for batch release Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands

2. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 0.2 ml reconstituted vaccine contains:

Active substances (lyophilisate): Inactivated Lawsonia intracellularis strain SPAH-08 5323 U1 1 Antigenic mass units as determined in the in vitro potency test (ELISA).

Adjuvant (solvent): Paraffin, light liquid 8.3 mg Dl-α-tocopheryl acetate 0.6 mg. Lyophilisate: white/nearly white pellet/powder. Solvent: homogenous white to nearly white emulsion after shaking. 4. INDICATION(S) For the active immunisation of pigs from 3 weeks of age to reduce diarrhoea, loss of daily weight gain, intestinal lesions, bacterial shedding and mortality caused by Lawsonia intracellularis infection.

Onset of immunity: 4 weeks after vaccination. Duration of immunity: 21 weeks after vaccination.

5. CONTRAINDICATIONS None.


6. ADVERSE REACTIONS An increase in body temperature very commonly occurs (mean 0.1°C, in individual pigs up to 1.4°C). The animals return to normal temperature within 1 day after vaccination. Local injection site reactions in the form of swelling may very commonly occur (mean diameter of approximately 1 cm, in individual pigs up to 5 cm). Local reactions disappear within 4 weeks after vaccination. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES Pigs.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Reconstitute the lyophilisate in the solvent or in Porcilis PCV ID as follows:

Lyophilisate Solvent for Porcilis Lawsonia ID or Porcilis PCV ID

50 doses 10 ml

100 doses 20 ml For proper reconstitution and correct administration, use the following procedure:

1. Allow the solvent or Porcilis PCV ID to reach room temperature and shake well before use. 2. Add approximately 5-10 ml of the solvent or Porcilis PCV ID to the lyophilisate vial and mix

briefly. 3. Withdraw the reconstituted concentrate from the vial and transfer it back into the vial with the

solvent or the Porcilis PCV ID. Shake briefly to mix. 4. Use the vaccine suspension within 6 hours of reconstitution. Any vaccine remaining at the end

of this time should be discarded. Dosage: A single dose of 0.2 ml of reconstituted vaccine in pigs starting at 3 weeks of age. Vaccinate pigs by the intradermal route using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin. Safety and efficacy of Porcilis Lawsonia ID have been demonstrated using the device IDAL. 9. ADVICE ON CORRECT ADMINISTRATION Avoid introduction of contamination by multiple broaching. Appearance after reconstitution: homogenous white to nearly white emulsion after shaking.


10. WITHDRAWAL PERIOD(S) Zero days.

11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.

Lyophilisate and solvent:

Store in a refrigerator (2C – 8C) . Do not freeze. Protect from light. Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life after reconstitution according to directions: 6 hours.

12. SPECIAL WARNING(S) Special warnings for each target species: Vaccinate healthy animals only. This vaccine is intended for intradermal administration only. The lyophilisate must be reconstituted in the dedicated “Solvent for Porcilis Lawsonia ID” or in Porcilis PCV ID following the instructions given in section on “Dosage for each species, route(s) and method of administration”.

Special precautions for use in animals: Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: To the user: This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again. To the physician: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon. Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Interaction with other medicinal products and other forms of interaction: Safety and efficacy data, except for protection against mortality, are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be mixed with Porcilis PCV ID. The product literature of Porcilis PCV ID should be consulted. Adverse reactions are as described in section on “Adverse reactions”, except for local injection site reactions where a maximum size of up to 7 cm may be observed in individual pigs. All local reactions disappear within 5 weeks after vaccination.


No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. Overdose (symptoms, emergency procedures, antidotes): No adverse reactions other than the local reactions described in the section “Adverse reactions” were observed after the administration of a double dose of Porcilis Lawsonia ID reconstituted in solvent. Incompatibilities: Do not mix the lyophilisate with any other veterinary medicinal product, except the recommended “Solvent for Porcilis Lawsonia ID” or the vaccine specified in the paragraph above regarding “Interaction with other medicinal products and other forms of interaction”.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED [to be completed nationally]

15. OTHER INFORMATION The vaccine stimulates active immunity against Lawsonia intracellularis in pigs. Pack sizes: Cardboard box with 1 x 50 doses of vaccine and cardboard box with 1 x 10 ml solvent. Cardboard box with 10 x 50 doses of vaccine and cardboard box with 10 x 10 ml solvent. Cardboard box with 1 x 100 doses of vaccine and cardboard box with 1 x 20 ml solvent. Cardboard box with 10 x 100 doses of vaccine and cardboard box with 10 x 20 ml solvent. Not all pack sizes may be marketed.

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